BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIGMA 6000+ PROG.(AB CALIBRATION)

    MDR report key: 80291 · Received March 27, 1997

    Report

    Report Number
    1221252-1997-00001
    Event Type
    Other
    Date Received
    March 27, 1997
    Date of Event
    February 12, 1997
    Report Date
    March 27, 1997
    Manufacturer
    SIGMA
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PT CLAIMED INFUSION PUMP INFUSED AT A HIGHER RATE THAN WAS PROGRAMMED. PT COMPLAINED OF PAIN WHICH WAS RELIEVED WHEN THE PUMP WAS DISCONNECTED. CYCLOSPORIN WAS BEING INFUSED. BIOMED TECH TESTED PUMP AFTER INCIDENT AND COULD NOT REPRODUCE ANY MALFUNCTION. DESPITE RECEIVING RETURN AUTHORIZATION FROM MFR TO RETURN PUMP FOR TESTING, NO RECORD OF THE PUMP'S RECEIPT AT MFR HAS BEEN REGISTERED AS OF 3-26-97.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA 6000+ PROG.(AB CALIBRATION) INFUSION PUMP FRN SIGMA SG 6000+PAB *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other